1. #ACIP will begin meeting at noon ET on the expansion of the emergency use authorizations for Pfizer & Moderna #Covid19 boosters.
The agenda is here: cdc.gov/vaccines/acip/…
The meeting can be listened to here: video.ibm.com/channel/VWBXKB…
I will be live blogging in this thread.
2. #ACIP is beginning. Roll call was conducted in an unusual fashion so I'm not sure I've got this right, but I think 2 voting members of the committee are not present (meeting was called at the last minute). So 13 members will be voting.
3. #ACIP is getting a bit of data on #Covid vax uptake in kids aged 5-11. So far nearly 2M kids have been vaccinated.
Matt Daley, chair of ACIP's Covid vax work group, says he's been talking to kids about vaccination. They're excited "not about the poke, but about the promise."
4. Daley is going through something I'd missed before. @CDC's Emergency Use Instructions outline additional uses of the Pfizer booster. It can be used as a boost for non-FDA authorized vaccines, ie AZ or other vaxes not used in the US, & for people who were in vax trials.
5. Pfizer is presenting data to #ACIP now. This is a breakdown of Grade 3 or higher reactions after a booster in a clinical trial the company ran.
6. The Pfizer representative, Dr. John Perez, vp for vaccine clinical research & development, just called a 55 year old woman "elderly."
I need a minute.
#ACIP
7. Pfizer's booster efficacy data, by demographic groups. #ACIP
8. Rituparna Das from Moderna is now presenting on their #Covid booster data. A reminder: The Moderna booster is a half dose (50 mcg) of their full dose (100 mcg). But it's still bigger than the Pfizer booster (30 mcg). #ACIP
9. Side effects reported after the Moderna booster were similar to those seen after earlier doses. The only side effect that was reported more frequently was swelling or tenderness of lymph nodes in the armpit. Similar to what Pfizer reported. #ACIP.
10. Moderna only filed for an EUA extension this wk & it feels like they weren't as ready to file as Pfizer was. Pfizer's presentation was 21 slides long; Moderna's was 5. Much less detail, including they don't have efficacy data. Das explained it wasn't placebo controlled. #ACIP
11. #ACIP is running late 20 minutes late. Just broke for a 4 minute break, to be followed by a 20 minute public comment session.
This meeting is unlikely to end at 3 pm, as scheduled.
12. #ACIP's public comment session ended early & the committee is plowing ahead. @CDCgov's Tom Shimabukuro is presenting on booster dose safety & the systems for soliciting information on vaccine side effects.
13. Shimabukuro presented this table, which is a bit confusing. But focus on the blue numbers — they show that 95% of Moderna vaccinees who have been boosted got Moderna for their booster. For Pfizer recipients, it was 99%,
14. Shimabukuro says in most cases, people who were boosted with the Pfizer vaccine had fewer reactions after dose 3 than after dose 2. #ACIP
15. One interesting take away from Shimaburuko's presentation: Most people who got an mRNA vaccine (which is most vaccinated Americans) stuck with their original vaccine when they got boosted. So much for mix-n-match.
16. Another interesting observation, as noted by @RandomlyBob: J&J recipients in the main have chosen mRNA vaccines as their boosters. Not sure that's a surprise. #ACIP
17. Shimabukuro reports from Sept 22 to Nov. 5, 54 cases of myocarditis were reported among the 26M people who have received boosters. Investigations suggest 12 are probably linked to vaccine receipt. The people are older, but people who have been getting boosted are older. #ACIP
18. #ACIP member Keipp Talbot tells the committee the data so far suggests #Covid boosters are safe. The Moderna booster appears to be the most reactogenic of the boosters. Not a surprise — it contains 1.66 times as much vaccine as the Pfizer booster.
19. In a Q&A session, Shimabukuro says it's too early to draw conclusions on the risk of myocarditis after the 3rd dose of mRNA vaccines, because teens and younger adults haven't yet been being boosted in big numbers. #ACIP
20. @CDCgov's Sara Oliver is now presenting. This is going to set up the decision(s) #ACIP will face. Anyone who wants to download the slides being presented at this meeting, they are here: cdc.gov/vaccines/acip/…
21. One of the factors driving the change to the booster eligibility criteria is the complexity of the current criteria. This survey, which Oliver presented to #ACIP, shows a fair percentage of people do not know if they're eligible or not — especially among the youngest adults.
22. Here's an illustration of how complex the current booster recommendations are:
23. And here's what the expanded eligibility would mean:
24. @nirav_mainecdc, president of the Association of State & Territorial Health Officials & a non-voting representative to #ACIP, said states unanimously support changing the eligibility criteria. Though well intentioned, the current criteria are an obstacle to boosting, he said.
25. #ACIP member Sarah Long, who hasn't been a fan of broad boosting, is indicating she supports giving people the choice to boost or not.
The vote to broaden the eligibility for boosters is going to pass.
26. #ACIP chair Grace Lee asks the committee if they should consider changing the wording of the recommendation for who "should" get a booster from 65 & older to 50 & older.
27. #ACIP member Matt Daley says a lot of people 50 to 64 should get boosters because of underlying health issues (Oliver says 75%), but restricting boosters to only those people is confusing people & probably preventing some people who qualify from getting one.
28. Sarah Long isn't comfortable with moving people 50-64 into the "should" category without more discussion — "in the last 5 minutes" before the vote.
To be clear, there hasn't been a motion moved yet.
If this change is made, the recommendations would look like this.
29. #ACIP is going to take 2 votes. Starting now.
30. This motion passed 11-0.
31. This motion passed 11-0.
There were only 11 votes because 2 members missed this meeting and 2 members — Sarah Long and Keipp Talbot — could not stay for the votes.
This meeting was put together very quickly and some of these people could not clear their calendar to attend.
32. #ACIP chair Grace Lee in adjourning meeting noted that this is the 22nd meeting that ACIP has held on #Covid vaccines. What she didn't say is that's almost twice the number of meetings an ACIP member would attend in a 4-year term in normal times. Huge workload.
33. The #ACIP recommendations now go to @CDCDirector, who will sign off on them some time today.

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More from @HelenBranswell

11 Nov
1. Europe is seeing an upswing in cases of an infection that has been linked to a polio-like phenomenon called #AFM — acute flaccid myelitis — according to a report today in @Eurosurveillanc. Enterovirus D68 is thought to trigger AFM in some kids. eurosurveillance.org/content/10.280…
2. From 2014 on, the US & Europe experienced cases of #AFM that left dozens of children dealing with some lingering paralysis after they had cold-like symptoms. AFM cases peaked every 2 years; but in socially-distance 2020, there was no surge. statnews.com/2021/02/04/doc…
3. Authorities in the US have been watching for #AFM this fall, figuring the loosening of Covid precautions & the return to in-person schooling could result in a spike in cases. So far this year that hasn't happened. Fewer cases than in 2020, even. cdc.gov/acute-flaccid-…
Read 4 tweets
5 Nov
1. Fridays are #flu update days from @CDCgov. So here goes.
CDC says flu activity remains low but the agency reports a tiny uptick in flu activity in the week ending Oct. 30. Image
2. To be honest, I don't actually see that. In the week ending Oct. 30, 52 people tested positive for #flu out of nearly 33,000 people tested. There's not a ton of sunlight between the test positivity rates of the first 4 weeks of the 2021-22 flu season. Image
3. Last week 282 people were admitted to hospital across the country because of #flu infections. It was 288 the week before. This number has been pretty static since late May. Image
Read 10 tweets
2 Nov
1. Good day. The Advisory Committee on Immunization Practices, #ACIP, is meeting today to review and vote on whether to recommend Pfizer's #Covid vaccine for children 5-11 yo.
The meeting is starting. It's expected to wrap about 5 pm ET today.
I'll be live tweeting.
2. The meeting opens with remarks from @CDCDirector, who called today a momentous day.
She acknowledges #Covid's risk to children is lower than adults, but it is not nil. 745 children under 18 have died; 94 were in the 5-11 age group.
School & childhood has been vastly changed.
3. @CDCDirector tells #ACIP that pediatric vaccination can help put kids' lives back on a normal track.
Read 52 tweets
26 Oct
1. A short #flu interlude:
@ECDC_EU released a statement today on flu in Europe warning of a potentially severe season looming for the elderly. It doesn't appear to be based on a ton, though flu activity seems to be higher than normal fo this time of year in Croatia.
2. @ECDC_EU's claim this might be a severe season for the elderly is based on the fact that most of the flu seen in the EU is H3N2, which is hard on seniors. This could be a bad year; no doubt about it. But this feels like not a ton of data on which to predict what's to come.
3. It also is timed to the launch of the @ECDC_EU's #flu awareness campaign. So there's that. ecdc.europa.eu/en/news-events…
Read 7 tweets
26 Oct
1. @US_FDA's Peter Marks opens the meeting acknowledging how heated the public debate on authorizing this vaccine for young children is. #VRBPAC members were hit with an organized campaign from anti-vaxers over the weekend. @DrPaulOffit told me he was getting an email a minute.
2. Acting #VRBPAC chair Arnold Monto, who is generally quick to cut off speakers when he wants to move the agenda onward, says lots of time has been allotted for today's meeting.
3. #VRBPAC is taking a short lunch break, till 1 pm ET. Then there's a 60 minute public comment period. Speakers are drawn by lottery, but I'd be very surprised if this isn't a very heated hour of comment.
Read 10 tweets
21 Oct
1. The #ACIP meeting on #Covid boosters is about to begin. Day long meeting. It will be interesting to see if they try to put some guard rails up around a pick-your-own-adventure booster process that @US_FDA seems to have green lit.
I will try to live tweet, but no promises.
2. If you want to listen to the meeting, here's the link: video.ibm.com/channel/VWBXKB…
3. CDC Director Rochelle Walensky, who overruled #ACIP the last time the committee met on #Covid vaccines, is addressing the committee now. No mention of having overruled ACIP.
Read 55 tweets

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